ANI Pharmaceuticals, Inc. announced that its ANDA collaboration partner Sofgen has received approval from the FDA of the Abbreviated New Drug Application (ANDA) for Nimodipine 30mg Capsules.
“This represents ANI's first ANDA approval with our partner Sofgen,” says Arthur S. Przybyl, president and CEO of ANI, in a released statement. “We are excited to have achieved this milestone and look forward to a successful launch.”
Modality Solutions announced hiring pharmaceutical veteran Judy Tempel as a principal consulting engineer. She will work on cold-chain technical support, storage, distribution, and accountability for clinical trials.
Tempel is currently responsible for clinical operations for vaccines for infectious diseases in challenging emerging markets.
Three pharmaceutical industry veterans with 80 years-combined experience were added to the growing life sciences roster at TraceLink Inc.
The three – Elizabeth Waldorf, Michael Ventura, and Marcel Zutter – have deep expertise in global serialization, product traceability, and supply chain transformation, and they are the latest to join a growing TraceLink team of 153 employees, which has increased by more than 80 percent since Jan. 1.
Gerresheimer AG announced its acquisition of Centor, a global supplier of prescription containers for medical dispensing, for $725 million. The move further extends Gerresheimer’s footprint in the pharmaceutical packaging business.
CPhI Korea announced it will return to the COEX in Seoul from Sept. 7-9 following a successful inaugural event in 2014. It is four events in one, being co-organized by the Korean Pharmaceutical Traders Association. The event brings together global suppliers and exhibitors for raw materials, machinery, contract services, finished dosage, and bio-solutions to engage on the delivery of pharmaceutical products across Asia and the world, will be co-located with ICSE, P-MEC, and BioPh.
ZIM Integrated Shipping Services announced its real-time cold chain transportation monitoring service ZiMonitor, aimed to give pharmaceutical companies and other transport essential industries a peace of mind.
G&K–Vijuk will introduce its new GUK-Sigma Pick & Pack Station at Pack Expo/Pharma Expo in Las Vegas in September.
Novo Nordisk announced the FDA’s approval of FlexPro PenMate, designed for users of Norditropin FlexPro 5 mg, 10 mg, and 15 mg pens who dislike needles and prefer them to be hidden during the injection process.
Teva Parenteral Medicines announced a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals, according to an FDA press release. A similar recall occurred in May.
Specialist carton and leaflet manufacturer and contract packer Chester Medical Solutions announces it has installed the first digital carton printer for Braille in the United Kingdom.